JP2021046748A - Facility construction method for constructing main facility that manufactures or produces one of pharmaceuticals, quasi drugs, medical equipment, products formed by processing cell, or products containing gene expressed within organism body - Google Patents

Abstract

To provide a facility construction method for construction based on one of a standard, a statute, or a guideline predefined with respect to a main facility.SOLUTION: A facility construction method herein is the method for constituting one or plural units included in a main facility respectively in place of the conventional facility construction method. The facility construction method includes preparing a building facility and a manufacturing facility that is installed within the building facility and is the facility forming a manufacturing facility storage space in the storage space of the building facility, specifying a building forming the building storage space capable storing a target facility, manufacturing one or plural units constituting the target facility by installing the building facility at a unit manufacturing factory and installing the manufacturing facility within the building facility, conveying the one or plural units from the unit manufacturing factory to the building for every units, carrying the one or plural units in the building storage space from the opening provided in the building for every units, and installing the main facility in the building storage space.SELECTED DRAWING: Figure 2

Description

The present invention is for constructing a main facility for producing or producing one of a drug, a non-pharmaceutical product, a medical device, a processed cell, or a gene contained in a living body. Related to equipment construction method.
In particular, the present invention has been introduced into equipment for producing pharmaceuticals or non-pharmaceutical products, equipment for producing medical devices used when performing treatments on patients, or processed cells or living cells. The present invention relates to an equipment construction method for constructing a main equipment, which is one of the equipments for producing one of the equipments containing a gene expressed in the body.

Equipment that produces pharmaceuticals or quasi-drugs is used.
Equipment that manufactures medical devices used to treat patients is used.
Equipment is used to produce one of the processed cells or one that is introduced into living cells and contains these genes expressed in the body.
In the following, equipment that produces pharmaceuticals or non-pharmaceutical products, equipment that manufactures medical equipment used in medical treatment, or equipment that has been processed into cells or introduced into living cells is introduced into these bodies. One of the facilities for producing one of those containing the expressed gene is called "main facility".

Standards, decree, or guidelines are established in advance in accordance with international standards in order for the equipment that produces pharmaceuticals or quasi-drugs to be used properly.
For example, in order to properly use equipment for producing pharmaceuticals or quasi-drugs, "production standards and quality control standards for pharmaceuticals and quasi-drugs" are set in advance.
For example, in order for a drug or quasi-drug production facility to be used properly, a Good Manufacturing Practice (hereinafter referred to as “GMP”) is defined in advance.

Standards, decree, or guidelines are set in advance to ensure proper use of equipment that manufactures medical devices used to treat patients.
For example, in order for equipment for manufacturing injection needles and vials to be used properly, the "Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals, Medical Devices, etc." is established in advance.
Here, the "Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals, Medical Devices, etc." is a Japanese law, and "Pharmaceuticals, non-pharmaceutical products, cosmetics, medical devices, regenerative medicine products, etc." In addition to taking necessary regulations to ensure quality, effectiveness and safety, and to prevent health hazards and spread of these specifications, and to take measures for the regulation of designated drugs, there is no particular medical need. The purpose is to improve health and hygiene by taking necessary measures to promote research and development of products such as pharmaceuticals, medical devices and regenerative medicine. "(Article 1)

Standards, decree, or guidelines in advance for proper use of equipment that produces processed cells or those that are introduced into living cells and contain genes that are expressed in the body. Is determined.
For example, in order to properly use equipment that produces processed cells or one that is introduced into living cells and contains genes expressed in the body, "regenerative medicine, etc.""Act on Ensuring Safety, etc." is established.
Here, the "Act on Ensuring the Safety of Regenerative Medicine, etc." is a Japanese law, which is "Measures Concerning Ensuring the Safety of Regenerative Medicine Technology Used in Regenerative Medicine, etc. and Consideration for Bioethics, etc." Promote the prompt and safe provision and dissemination of regenerative medicine, etc. by clarifying the measures to be taken by those who intend to provide regenerative medicine, etc. The purpose is to contribute to the improvement of medical quality and health and hygiene. "(Article 1)

For example, one of those obtained by processing cells or those containing genes that are introduced into living cells and expressed in the body is a product such as regenerative medicine.
"Products such as regenerative medicine" are defined in the Japanese law "Act on Securing Quality, Effectiveness and Safety of Pharmaceuticals and Medical Devices".
The term "regenerative medicine products" as used in this Act means the following products (excluding quasi-drugs and cosmetics) specified by Cabinet Order. (Article 2.9)
No. 1 Among the following medical or veterinary medical treatments, those in which human or animal cells are cultured or otherwise processed a. Reconstruction of the structure or function of the human or animal body , Repair or formation (b) Treatment or prevention of human or animal diseases No. 2 Among those intended to be used for the treatment of human or animal diseases, which are introduced into human or animal cells and are introduced into these bodies. In the following, one of the predetermined standards, laws, or guidelines for the main equipment is referred to as "standards / laws / guidelines".

By the way, in recent years, the following social problems have occurred.
When a drug patent expires, generic drug producers will emerge and the performance of existing pharmaceutical companies will deteriorate.
With the international standardization of pharmaceutical manufacturing approval (inspection) standards, the equipment standards of pharmaceutical manufacturing plants will be changed.
With the progress of advanced medicine, the demand for medicines based on individual genes, antibodies, cell processing and other technologies will increase.

Therefore, the following problems must be resolved.
In the production of small-lot, high-mix pharmaceutical products, it takes time and effort to clean the fixed equipment to prevent cross-contamination.
It takes time to operate pharmaceutical production.
For example, process management becomes complicated because the process of constructing a pharmaceutical production line is incorporated into the process of building a building.
For example, in order to satisfy the examination criteria for pharmaceutical production (for example, GMP), complicated eligibility evaluation is performed over the entire process during designing up to operation, before factory shipment, equipment installation, test run, and actual operation. Needs.

It is known to use equipment technology for a single purpose (referred to as "single use") instead of fixed equipment in order to solve some of the above problems.
On the premise of this, the inventors examined a technology capable of exerting the following effects.
Utilize the space of the building that has already been completed and omit the construction process. For example, a logistics facility has a high degree of freedom in using the building space and has a floor surface that can withstand the installation of heavy objects.
By prefabricating the rooms for pharmaceutical production and arranging them appropriately on the existing floor, the procedure for constructing a production line at the construction site will be simplified.
Prefabricated single or multiple rooms will be pre-equipped with pharmaceutical production equipment, and the equipment work at the construction site will be omitted.
This prefab is equipment constructed by the method of the present application.
Most of the eligibility evaluation of pharmaceutical production equipment will be evaluated ahead of schedule when it is prefabricated, and the evaluation management at the construction site will be omitted.
At the same time as prefabricating one or more rooms, prefabricated functions according to the movement characteristics of raw materials, intermediate products, final products, waste, etc. and the changing flow lines of workers, maintenance personnel, inspectors, etc. Reduce special renovation work on existing buildings.
In order to minimize the renovation work of the existing building, the unit shall have disposable or reusable containers with a replaceable structure for carrying in and out equipment for things and things necessary for the movement characteristics of people.
An object of the present invention is to simplify the procedure for constructing a production line at a construction site by prefabricating a room for pharmaceutical production and appropriately arranging it on an existing floor surface.

JP 2012-187016 Japanese Unexamined Patent Publication No. 2013-253761 Japanese Patent Application Laid-Open No. 9-222247 JP-A-2009-002634 Japanese Unexamined Patent Publication No. 2011-257019 JP 2011-257018 Japanese Unexamined Patent Publication No. 2017-048941 Japanese Patent Application Laid-Open No. 2000-018663

As a result, the inventors have found that, for example, load-bearing the existing floor and high floor height ceiling for the logistics of the 2 t / m ² degree, in the large space consisting of a roof, shorten the time until the operation from the planning of the factory To enable this, we devised an equipment construction method characterized by appropriately arranging box-shaped units containing main functions and utilities in advance to form a production line including the main equipment.

To achieve the above objectives, we will build the main equipment to produce or manufacture pharmaceuticals, non-pharmaceutical products, medical devices, processed cells, or those containing genes expressed in the body of the living body. The equipment construction method for this is the building equipment and the building equipment, which are the equipment that forms the storage space for the building equipment, which is the equipment that forms the storage space inside, which is composed of one or more units that make up the main equipment. The building equipment / production equipment preparation process for preparing the production equipment, which is the equipment that forms the production equipment storage space, which is the storage space located inside the building equipment storage space, and the storage that can store the main equipment. A building identification process for specifying a building that forms the building storage space, which is a space, and a single or a plurality of installations of the building equipment in a unit manufacturing factory, which is a factory, and the production equipment installed in the building equipment. A unit manufacturing process for manufacturing the unit, a unit transporting process for transporting one or more of the units from the unit manufacturing factory to the building, and a unit carrying process for transporting the single or a plurality of the units from the opening provided in the building for each unit. It is provided with a unit carry-in step of carrying into the building storage space and a unit installation step of installing one or more of the units in the building storage space.

In the above-described configuration of the present invention, the building equipment / production equipment preparation process constitutes each of a single unit or a plurality of units constituting the main equipment, and is supported by the skeleton and the skeleton and is a storage space inside the building equipment storage. In the process of preparing building equipment that forms a space and production equipment that is installed inside the building equipment and is a storage space located inside the building equipment storage space. is there. The building identification process is a process of specifying a building that forms the building storage space, which is a storage space that can store the main equipment. The unit manufacturing process is a step of installing the building equipment in a unit manufacturing factory, which is a factory, and installing the production equipment in the building equipment to manufacture one or more of the units. The unit transporting process is a step of transporting one or more of the units from the unit manufacturing factory to the building. The unit loading step is a step of loading a single unit or a plurality of the units into the building storage space through an opening provided in the building for each unit. The unit installation step is a step of installing one or more of the units in the building storage space.
As a result, the main equipment can be efficiently installed in the building.

The equipment construction method according to the embodiment of the present invention will be described below. The present invention includes any of the embodiments described below, or a combination of two or more of them.

Further, in the equipment construction method according to the embodiment of the present invention, the main equipment is composed of a plurality of the units arranged in series or in parallel according to a specific order, which is a specific order, and the main equipment specifies the plurality of the units. By connecting the building equipment of a plurality of the units by arranging them in series or in parallel according to the order, the production equipment of the plurality of the units can be connected, and the unit installation process is performed in the building storage space of the building. This is a step of arranging a plurality of the units directly or in parallel according to the specific order, connecting the building equipment of the plurality of units, connecting the production equipment of the plurality of units, and installing the single or a plurality of the units. ..
According to the configuration of the embodiment according to the present invention, the main equipment is composed of a plurality of the units arranged in series or in parallel according to a specific order, which is a specific order. The main equipment is such that when the plurality of the units are arranged in series or in parallel according to the specific order and the building equipment of the plurality of units is connected, the production equipment of the plurality of units can be connected. In the unit installation step, a plurality of the units are arranged directly or in parallel according to the specific order in the building storage space of the building, and the building equipment of the plurality of units is connected to form the production equipment of the plurality of units. This is a step of connecting and installing one or more of the above units.
As a result, the main equipment in which the plurality of the units are connected can be efficiently installed in the building.

Further, the equipment construction method according to the embodiment of the present invention includes an auxiliary member carry-in step of carrying the auxiliary member into the building storage space, and the auxiliary member can support all the units constituting the main equipment. Alternatively, the unit has a plurality of long members, and the unit installation process installs the single or a plurality of the units on the single or a plurality of the auxiliary members installed in the building storage space of the building. It is a process to do
According to the configuration of the embodiment according to the present invention, in the auxiliary member carrying-in step, the auxiliary member is carried into the building storage space. The auxiliary member has one or more elongated members capable of supporting all the units constituting the main equipment. The unit installation step is a step of installing the single or a plurality of the units on the single or a plurality of the long members of the auxiliary member installed in the building storage space of the building.
As a result, the main equipment can be efficiently installed on the auxiliary members in the building.

Further, the equipment construction method according to the embodiment of the present invention includes an auxiliary member carry-in step of carrying the auxiliary member into the building storage space, and all the units in which the auxiliary member extends in the horizontal direction and constitutes the main equipment. It has a single or a plurality of long members capable of supporting the unit and a guide member capable of guiding the unit supported by the long member, and the unit carrying-in process involves the single or a plurality of the units being provided through an opening provided in the building. This is a step in which each unit is supported by a single or a plurality of the long members and guided by the guide members to be carried into the building storage space.
According to the configuration of the embodiment according to the present invention, the auxiliary member carrying-in step is a step of carrying the auxiliary member into the building storage space. The auxiliary member extends in the horizontal direction and has one or a plurality of long members capable of supporting all the units constituting the main equipment, and a guide member capable of guiding the unit supported by the long member. The unit carry-in step is a step of supporting a single or a plurality of the units by a single or a plurality of the long members for each unit through an opening provided in the building and guiding the units to the building storage space. Is.
As a result, the main equipment composed of one or a plurality of the above units can be efficiently installed on the auxiliary members in the building.

Further, the equipment construction method according to the embodiment of the present invention includes an auxiliary member carry-in step of carrying the auxiliary member into the building storage space, and all the units in which the auxiliary member extends in the horizontal direction and constitutes the main equipment. It has one or a plurality of long members capable of supporting the long member and a guide member capable of guiding the unit supported by the long member along the longitudinal direction of the long member so as to move on the long member. Then, in the unit carrying-in step, the single or a plurality of the units are supported by the single or a plurality of the long members for each unit through an opening provided in the building, and the long members are supported along the longitudinal direction of the long members. This is a step of being guided by the guide member so as to move on the member and being carried into the building storage space.
According to the configuration of the embodiment according to the present invention, the auxiliary member carrying-in step is a step of carrying the auxiliary member into the building storage space. The auxiliary member extends in the horizontal direction to support all the units constituting the main equipment, and the unit is supported by the long member along the longitudinal direction of the long member. It has a guide member that can guide the user to move on the long member. In the unit loading step, one or a plurality of the units are supported by the one or a plurality of the long members for each unit from an opening provided in the building, and the long members are supported along the longitudinal direction of the long members. This is a process of being guided by the guide member so as to move on the building and being carried into the building storage space.
As a result, the main equipment composed of one or a plurality of the above units can be efficiently installed on the auxiliary members in the building.

Further, the equipment construction method according to the embodiment of the present invention includes an auxiliary member carry-in step of carrying the auxiliary member into the building storage space, and all the units in which the auxiliary member extends in the horizontal direction and constitutes the main equipment. It is possible to guide a single or a plurality of long members capable of supporting the unit and the unit supported by the long members so as to move on the floor forming the building storage space of the building together with the long members. It has a guide member, and in the unit loading process, one or a plurality of the units are supported by the single or a plurality of the long members for each unit from an opening provided in the building and integrated with the long member. This is a step of being guided by the guide member so as to move on the floor forming the building storage space of the building and carried into the building storage space.
According to the configuration of the embodiment according to the present invention, the auxiliary member carrying-in step is a step of carrying the auxiliary member into the building storage space. A single or a plurality of long members capable of supporting all the units constituting the main equipment in which the auxiliary member extends in the horizontal direction and the unit supported by the long member are integrated with the long member in the building. It has a guide member that can guide the user to move on the floor forming the building storage space. In the unit loading process, the unit or a plurality of the units are supported by the single or a plurality of the long members for each unit from the opening provided in the building, and the unit is integrated with the long members to provide the building storage space of the building. This is a step of being guided by the guide member so as to move on the floor to be formed and carried into the building storage space.
As a result, the main equipment composed of one or a plurality of the above units can be efficiently installed on the auxiliary members in the building.

Further, the equipment construction method according to the embodiment of the present invention includes an auxiliary member carrying-in step of carrying the auxiliary member into the building storage space, and the unit manufacturing process is integrated in a unit manufacturing factory which is a factory. After adjusting the level of the auxiliary member and installing it in one of the assembled states of the divided parts, the building equipment is installed on the auxiliary member by adjusting the level of the building. It is a process of manufacturing a single unit or a plurality of the units by adjusting the level of the production equipment in the equipment, and the unit installation process is an integrated state or a division in the building storage space of the building. This is a step of installing one or a plurality of the units after adjusting the level of the auxiliary member in one of the assembled states.
According to the configuration of the embodiment according to the present invention, in the auxiliary member carrying-in step, the front auxiliary member is carried into the building storage space. In the unit manufacturing process, the auxiliary member is installed after adjusting the level in either the integrated state or the assembled state of the divided parts at the unit manufacturing factory, which is a factory. It is a step of manufacturing one or a plurality of the above-mentioned units by adjusting the level of the building equipment and installing the above-mentioned building equipment and adjusting the level of the production equipment in the building equipment. In the unit installation process, one or a plurality of the auxiliary members are installed after adjusting the level of the auxiliary member in either one of the integrated state or the divided state in the building storage space of the building. This is the process of installing the unit.
As a result, the main equipment can be efficiently installed in the building.

Further, the equipment construction method according to the embodiment of the present invention includes an auxiliary member carrying-in step of carrying the auxiliary member into the building storage space, and the unit manufacturing process is integrated in a unit manufacturing factory which is a factory. After the auxiliary member, which is in one of the assembled states of the divided parts, is supported at a specific place which is a preset specific place, the level is adjusted, and then the auxiliary member is installed. This is a step of adjusting the level of the building equipment and installing the building equipment on the building and installing the production equipment in the building equipment by adjusting the level of the building equipment to manufacture one or more of the units. Supports the auxiliary member, which is in either the integrated state or the assembled state of the divided building in the building storage space of the building, at a preset specific position and adjusts the level. It is a process of installing one or more of the units after installation, and the specific location corresponds to a position of a beam supporting the floor of the building that forms the building storage space when the unit is installed in the building. It is a specific place preset in the auxiliary member.
According to the configuration of the embodiment according to the present invention, the auxiliary member carrying-in step is a step of carrying the auxiliary member into the building storage space. The unit manufacturing process is a specific place where the auxiliary member is preset, which is either a state of being integrated or a state of being assembled in a divided state at a unit manufacturing factory, which is a factory. After the level is adjusted and installed, the building equipment is level-adjusted and installed on the auxiliary member, and the production equipment is level-adjusted and installed in the building equipment. Alternatively, it is a process of manufacturing a plurality of the above units. In the unit installation step, the auxiliary member, which is either one of the integrated state or the divided state in the building storage space of the building, is supported at the specific position set in advance. This is a step of installing one or more of the above units after adjusting the level and installing the unit. The specific location is a specific location preset on the auxiliary member corresponding to a position of a beam supporting the floor of the building that forms the building storage space when the unit is installed in the building.

Further, the equipment construction method according to the embodiment of the present invention is a long member made of a lattice beam in which the long members are combined in a rectangular shape when viewed from above.
According to the configuration of the embodiment according to the present invention, the long member is a long member made of a lattice beam in which the long members are combined in a rectangular shape when viewed from above.
As a result, a lightweight and highly rigid auxiliary member can be realized.

As described above, the equipment construction method according to the present invention has the following effects depending on its configuration.
The main equipment is composed of the above-mentioned unit having the building equipment and the production equipment forming the production equipment storage space provided in the building equipment storage space of the building equipment, and the building forming the building storage space is prepared and the unit manufacturing factory. The production equipment is installed in the building equipment to manufacture the unit, and each unit is transported from the unit manufacturing factory to the building, and each unit is carried into the building storage space of the building through the opening of the building and mainly in the building storage space. Since the equipment is installed, the main equipment can be installed efficiently in the building.
Further, the plurality of the units are arranged directly or in parallel according to a specific order, the building equipment of the plurality of the units is connected, the production equipment of the plurality of the units is connected, and the main equipment is installed in the building storage space of the building. Therefore, the main equipment in which the plurality of the units are connected can be efficiently installed in the building.
Further, since the main equipment is installed on the long member of the auxiliary member installed in the building storage space, the main equipment can be efficiently installed in the building.
Further, since the single or a plurality of the units are supported by the long member for each unit from the opening provided in the building and guided by the guide member to be carried into the building storage space, the single or a plurality of the units are described. The main equipment composed of units can be efficiently installed on the auxiliary members in the building.
Further, one or a plurality of the units are carried into the building storage space by being guided by the guide member so as to be supported by the long member for each unit from an opening provided in the building and move on the long member. Therefore, the main equipment composed of one or more of the above units can be efficiently installed on the auxiliary members in the building.
In addition, one or more of the units are supported by the long member for each unit from an opening provided in the building, and the guide member is guided so as to move on the floor of the building integrally with the long member. Since it is carried into the building storage space, the main equipment composed of one or a plurality of the units can be efficiently installed on the auxiliary member in the building.
In addition, one or more of the above-mentioned units manufactured by level-adjusting and installing the building equipment on the auxiliary member whose level has been adjusted at the manufacturing plant and installing the production equipment in the building equipment by adjusting the level. Since the building equipment was installed by adjusting the level on the auxiliary members installed by transporting and adjusting the level in the building storage space of the building, the main equipment was installed efficiently in the building. Can be installed.
In addition, just as the beam of the building supports a specific part of the auxiliary member, the building equipment is installed by adjusting the level on the auxiliary member that supports the specific part and the level is adjusted at the manufacturing factory, and inside the building equipment. The building equipment is installed on the auxiliary member that is installed by adjusting the level of the production equipment and transporting one or more of the above-mentioned units, supporting it at a specific location in the building storage space of the building, and adjusting the level. Since the level is adjusted and installed to install the main equipment, the main equipment can be installed efficiently in the building.
Further, since the long member is made to be a long member made of lattice beams combined in a rectangular shape when viewed from above, a lightweight and highly rigid auxiliary member can be realized.
As a result, it is possible to provide a facility construction method characterized by simplifying the procedure for constructing a production line at a construction site by prefabricating a room for pharmaceutical production and appropriately arranging it on an existing floor surface.

It is a conceptual diagram of the unit which concerns on embodiment of this invention. It is a top view of the main equipment which concerns on embodiment of this invention. FIG. 1 is a flow chart of a facility construction method according to the first embodiment of the present invention. FIG. 2 is a flow chart of a facility construction method according to the first embodiment of the present invention. It is a front view of the main equipment which concerns on 1st Embodiment of this invention. It is a side view of the main equipment which concerns on 1st Embodiment of this invention. It is an operation explanatory drawing of the equipment construction method which concerns on 1st Embodiment of this invention. FIG. 1 is a flow chart of a facility construction method according to a second embodiment of the present invention. FIG. 2 is a flow chart of a facility construction method according to a second embodiment of the present invention. It is a side view of the main equipment which concerns on 2nd Embodiment of this invention. It is operation explanatory drawing 1 of the equipment construction method which concerns on 2nd Embodiment of this invention. FIG. 2 is an operation explanatory view of the equipment construction method according to the second embodiment of the present invention. It is a structural explanatory drawing of the auxiliary member which concerns on embodiment of this invention.

Hereinafter, the best mode for carrying out the present invention will be described with reference to the drawings.

The equipment construction method according to the embodiment of the present invention is a method of constructing a main equipment.
The equipment construction method according to the embodiment of the present invention is a method for constructing the main equipment in accordance with the standards / decree / guidelines.

First, the main equipment according to the embodiment of the present invention will be described.
The main equipment is equipment that produces pharmaceuticals or non-pharmaceutical products, equipment that manufactures medical equipment used when treating patients, or equipment that has been processed into cells or introduced into living cells and introduced into these bodies. It is one of the facilities for producing one of those containing the gene expressed in.
FIG. 2 shows an example of the main equipment.

The equipment construction method according to the first embodiment of the present invention will be described with reference to the drawings.
FIG. 3 is a flow chart No. 1 of the equipment construction method according to the first embodiment of the present invention. FIG. 4 is a flow chart No. 2 of the equipment construction method according to the first embodiment of the present invention. FIG. 5 is a front view of the main equipment according to the first embodiment of the present invention. FIG. 6 is a side view of the main equipment according to the first embodiment of the present invention. FIG. 7 is an operation explanatory view of the equipment construction method according to the first embodiment of the present invention.

The equipment construction method according to the first embodiment of the present invention includes a building equipment / production equipment preparation process S10, a unit manufacturing process S20, a unit transportation process S40, a unit transfer process S50, and a unit installation process S60.
The equipment construction method according to the first embodiment of the present invention includes a building equipment / production equipment preparation process S10, a unit manufacturing process S20, a unit transportation process S40, an auxiliary member loading process S45, a unit loading process S50, and a unit installation process S60. It may be composed of.
The equipment construction method according to the first embodiment of the present invention includes a building equipment / production equipment preparation process S10, a unit manufacturing process S20, an validity confirmation process S30, a unit transportation process S40, a unit loading process S50, and a unit installation process S60. It is also convenient because it is composed of the overall validity confirmation step S70.
The equipment construction method according to the first embodiment of the present invention includes a building equipment / production equipment preparation process S10, a unit manufacturing process S20, an validity confirmation process S30, an auxiliary member loading process S45, a unit transporting process S40, and a unit loading process S50. It may be composed of the unit installation step S60 and the overall validity confirmation step S70.
The equipment construction method according to the first embodiment of the present invention includes a building equipment / production equipment preparation process S10, a plurality of unit manufacturing processes S20, a plurality of validity confirmation processes S30, an auxiliary member loading process S45, and a unit transportation process S40. It may be composed of a unit carry-in step S50, a unit installation step S60, and an overall validity confirmation step S70.

The building equipment / production equipment preparation step S10 is a step of preparing the building equipment 11 and the production equipment 12 which each constitute a single unit or a plurality of units 10 constituting the main equipment.
The building equipment / production equipment preparation step S10 may be a step of preparing the building equipment 11 and the production equipment 12 which each constitute a single unit 10 constituting the main equipment.
The building equipment / production equipment preparation step S10 may be a step of preparing the building equipment 11 and the production equipment 12 which each constitute a plurality of units 10 constituting the main equipment.
FIG. 1 shows the singular unit 10.
FIG. 1A shows the building equipment 11 installed in the factory.
FIG. 1B shows the building equipment 11 and the production equipment 12 installed in the factory.
FIG. 1C shows a unit 10 installed in a factory.
FIG. 1D shows a unit 10 installed in a building.
FIG. 1 (E) shows a state in which other auxiliary equipment is attached to the unit installed in the building.

The building equipment 11 is a facility that forms a building equipment storage space inside.
The building equipment 11 may be equipment having a skeleton and a panel supported by the skeleton and forming a building equipment storage space inside.
FIG. 1 (A) shows the framework of the building equipment 11 without the panel.

The production equipment 12 is equipment that is installed in the building equipment and forms the production equipment storage space E1 located in the building equipment storage space E2.
FIG. 1B shows how the production equipment 12 is installed in the building equipment storage space E2 of the building equipment 11.

The main equipment 50 may be composed of a plurality of units 10 arranged in series or in parallel according to a specific order, which is a specific order.
The main equipment 50 may be capable of connecting the production equipment of a plurality of units by arranging the plurality of units 10 in series or in parallel in a specific order and connecting the building equipment of the plurality of units.
The main equipment 50 is such that when a plurality of units 10 are arranged in series or in parallel in a specific order and the building equipment of a plurality of units is connected in series or in parallel in a specific order, the production equipment of a plurality of units can be connected in series or in parallel in a specific order. It may be.
FIG. 5 shows that when a plurality of units 10 are arranged in series in a specific order and the building equipment of the plurality of units is connected in series in a specific order, the production equipment of the plurality of units can be connected in series in a specific order. Shown.

The building specifying step S15 is a step of specifying a building forming a building storage space E3 capable of storing the main equipment 50.
The building 100 is a building having a floor capable of supporting the main equipment 50 and forming a building storage space E3 capable of exerting a predetermined function.
For example, the building 100 is a building having a floor capable of supporting a pharmaceutical product or a quasi-drug production facility and a storage space capable of exerting a function of moving the weight thereof.
The building 100 may have a resource supply function capable of supplying necessary resources to a drug or quasi-drug production facility.

When operating the main equipment 50, the pressures of the production equipment storage space E1, the building equipment storage space E2, and the building storage space E3 may be different.
For example, the pressure of the production equipment storage space E1 and the pressure of the building equipment storage space E2 are different.
For example, the pressure of the production equipment storage space E1 is lower than the pressure of the building equipment storage space E2.
In this way, it is possible to prevent minute objects from leaking from the production equipment storage space E1 to the building equipment storage space E2.
For example, the pressure of the building equipment storage space E2 and the pressure of the building storage space E3 are different.
For example, the pressure of the building equipment storage space E2 is lower than the pressure of the building storage space E3.
In this way, it is possible to prevent minute objects from leaking from the building equipment storage space E2 to the building storage space E3.

The unit manufacturing process S20 is a step of installing the building equipment 11 in the unit manufacturing factory 200, which is a factory, and installing the production equipment 12 in the building equipment 11 to manufacture a single unit or a plurality of units 10.
The unit manufacturing process S20 is a process in which the building equipment 11 is installed in the unit manufacturing factory 200, which is a factory, and the production equipment 12 is installed in the building equipment 11 to manufacture a single unit or a plurality of units 10. is there.
In the unit manufacturing process S20, one or a plurality of units constituting the main equipment 50 by installing the building equipment 11 in the unit manufacturing factory 200, which is a factory, and installing the production equipment 12 in the building equipment 11 for each unit. It may be a step of manufacturing 10.

In the unit manufacturing process S20, the auxiliary member 20 is level-adjusted and installed at the unit manufacturing factory 200, which is a factory, and then the building equipment 11 is level-adjusted and installed on the auxiliary member 20 in the building equipment. It may be a process of manufacturing a single unit or a plurality of units by adjusting the level of the production equipment 12 and installing the production equipment 12.
In the unit manufacturing process S20, the auxiliary member 20 is level-adjusted and installed at the unit manufacturing factory 200, which is a factory, and then the building equipment 11 is level-adjusted and installed on the auxiliary member 20 for each unit. It may be a process of manufacturing a single unit or a plurality of units by installing the production equipment 12 in the equipment by adjusting the level.
In the unit manufacturing process S20, the auxiliary member 20 which is in either the integrated state or the assembled state of the unit manufacturing factory 200, which is a factory, is installed by adjusting the level for each unit. After that, the building equipment 11 is level-adjusted and installed on the auxiliary member 20, and the production equipment 12 is level-adjusted and installed in the building equipment to manufacture one or more units. May be good.

In the unit manufacturing process S20, the auxiliary member 20 is supported at a specific place which is a preset specific place in the unit manufacturing factory 200 which is a factory, the level is adjusted, and then the auxiliary member 20 is installed on the auxiliary member 20. 11 may be level-adjusted and installed, and the production equipment 12 may be level-adjusted and installed in the building equipment 11 to manufacture a single unit or a plurality of units 10.
In the unit manufacturing process S20, the auxiliary member 20 is supported at a specific place which is a preset specific place in the unit manufacturing factory 200 which is a factory, the level is adjusted, and then the auxiliary member 20 is placed on the auxiliary member for each unit. It may be a process of manufacturing a single unit or a plurality of units by adjusting the level of the building equipment and installing the production equipment in the building equipment by adjusting the level.
The unit manufacturing process S20 is a specific place where the auxiliary member 20 which is one of the integrated state and the assembled state of the unit manufacturing factory 200, which is a factory, is preset. After supporting and installing at a location and adjusting the level, the building equipment 11 is installed by adjusting the level on the auxiliary member 20, and the production equipment 12 is installed by adjusting the level in the building equipment 11. It may be a step of manufacturing a single unit or a plurality of units 10.

The specific location is a location preset in the auxiliary member 20 corresponding to the position of the beam supporting the floor of the building forming the building storage space E3 when the unit 10 is installed in the building 100.
For example, the specific location corresponds to the position where the beam supporting the floor of the building 100 forming the building storage space E3 and the long member 21 intersect when the unit 10 is installed in the building 100 when viewed from above. This is a preset location on the auxiliary member 20.
For example, when the unit 10 is installed in the building 100, the specific location is the auxiliary member 20 in which the beam supporting the floor of the building 100 forming the building storage space E2 and the long member 21 intersect when viewed from above. It is a place.

When the girders and girders support the floor, the specific location is an auxiliary member corresponding to the position of the girders that support the floor of the building that forms the building storage space E3 when the unit 10 is installed in the building 100. It may be a preset location.
When the girders and girders support the floor, the specific location corresponds to the location of the girders and girders that support the floor of the building that forms the building storage space E3 when the unit 10 is installed in the building 100. It may be a place preset in the auxiliary member.

Here, the auxiliary member 20 has a long member 31 that can support all the units constituting the main equipment.
The auxiliary member 20 may have an integral structure.
The auxiliary member 20 may have a structure that can be divided into a plurality of parts.
The long member 21 is a long member made of a molded steel material, a lattice beam, or the like.
The long member 21 may be one of a molded steel material, a lattice beam, a plate beam, and a truss beam.
Here, the auxiliary member 20 has a long member 11 capable of simultaneously supporting all the units constituting the main equipment.
A long member 21 in which the auxiliary member 20 extends in the horizontal direction and can support all the units constituting the main equipment, and a guide member 22 capable of guiding the unit supported by the long member 21 along the longitudinal direction of the long member 21. And may have.
A single or a plurality of long members 21 in which the auxiliary member 20 extends in the horizontal direction and can simultaneously support all the units constituting the main equipment, and a unit supported by the long members 21 along the longitudinal direction of the long members 21. It may have a guide member 22 that can guide.
A plurality of long members 21 may be assembled in series or in parallel in the long direction to be integrated.

The long member 21 may be a long member made of a plurality of lattice beams in which the long members 21 are combined in a rectangular shape when viewed from above.
For example, the long member 21 may be a long member made of four lattice beams in which the long members 21 are combined in a rectangular shape when viewed from above.
FIG. 13 shows a long member made of four lattice beams in which the long members 21 are combined in a rectangular shape when viewed from above.
FIG. 13 further shows a state in which a flange for connecting the long members to each other is provided at the end portion of the long member 21 in the longitudinal direction.
FIG. 13 shows a state in which the level adjusting jig 26 is provided at the rectangular corner of the long member 21 when viewed from above.

A single or a plurality of long members 21 in which the auxiliary member 20 extends in the horizontal direction and can support all the units constituting the main equipment, and a unit 10 supported by the long members 21 along the longitudinal direction of the long members 21. It may have a guide member that can guide the long member 21 so as to move on the long member 21 along the longitudinal direction.
In FIG. 6, the auxiliary member 20 supports the long member 21 and the unit supported by the long member 21 along the longitudinal direction of the long member 21 on the long member 21 along the longitudinal direction of the long member 21. It is shown that it has a guide member 22 that can guide the movement.

The unit manufacturing process S20 may be executed in one unit manufacturing factory.
The unit manufacturing process S30 may be executed for each unit in a plurality of unit manufacturing factories.
A plurality of units may be grouped into a plurality of groups, and the unit manufacturing step S30 may be executed for each group at a plurality of unit manufacturing factories.
FIG. 3 shows a flow of executing the unit manufacturing process S20 in one unit manufacturing factory.
FIG. 4 shows a flow in which the unit manufacturing process S20 is executed for each unit or for each set of the plurality of units 10 in a plurality of unit manufacturing factories.

The validation step S40 is a step of validating a single unit or a plurality of units for manufacturing in accordance with a standard / decree / guideline which is one of predetermined standards, decree, or guidelines.
The validity confirmation step S40 is a step of confirming the validity for manufacturing in accordance with the standard / decree / guideline which is one of the predetermined standards, decree, or guidelines for a plurality of units for each unit. You may.

The validation step S40 may be performed for all units 10 in one unit manufacturing plant.
The validation step S40 may be executed for each unit in a plurality of unit manufacturing factories.
A plurality of units may be grouped into a plurality of groups, and the validation step S40 may be executed for each group at a plurality of unit manufacturing factories.
FIG. 2 shows how the validation step S40 is executed in one unit manufacturing factory.
FIG. 3 shows how the validation step S40 is executed for each unit or each set at a plurality of unit manufacturing factories.

The unit transportation step S40 is a step of transporting a single unit or a plurality of units 10 from the unit manufacturing factory to the building.
The unit transportation step S40 may be a step of transporting a single unit or a plurality of units 10 from the unit manufacturing factory to the building for each unit.
The unit transportation step S40 may be a step of mounting a single unit or a plurality of units 10 on a vehicle for each unit and transporting the unit from the unit manufacturing factory 200 to the building 100.

The auxiliary member carry-in step S45 is a step of carrying in the auxiliary member 20 into the building.
The auxiliary member 20 may be the one used in the unit manufacturing process S20.
The auxiliary member 20 may be dedicated to the building 100.
The auxiliary member 20 may be carried into the building 100 and installed so as to be supported by a plurality of beams of the building 100.

The unit loading step S50 is a step of loading a single unit or a plurality of units 10 into the building storage space of the building through an opening provided in the building for each unit.
The unit loading step S50 is a step of loading a plurality of units 10 into the building storage space E3 of the building 100 through an opening provided in the building 100 for each unit.

The unit carry-in step S50 is a step in which one or more units 10 are supported by one or more long members 21 for each unit from an opening provided in the building and guided by the guide member 22 to be carried into the building storage space of the building. There may be.

In the unit carry-in step S50, one or a plurality of units are supported by a single or a plurality of long members 21 for each unit from an opening provided in the building, and are guided by the guide member 22 in a specific order and carried into the building storage space E3 of the building. It may be a step to do.

In the unit loading step S50, one or more units 10 are supported by one or more long members 21 for each unit from an opening provided in the building 100, and the long members 21 are supported along the longitudinal direction of the long members 21. It may be a step of being guided by the guide member 22 so as to move on the building and being carried into the building storage space E3.

The unit installation step S60 is a step of installing a single unit or a plurality of units 10 in the building storage space E3 of the building 100.
The unit installation step S60 is a step of installing a single unit or a plurality of units 10 in the building storage space E3 of the building 100 to construct the main equipment.

In the unit installation step S60, a plurality of units 10 are installed directly or in parallel in a specific order in the building storage space E3 of the building, and the building equipment 11 of the plurality of units 10 is connected to form the production equipment 12 of the plurality of units 10. It may be a step of connecting and installing a single unit or a plurality of units 10.

The unit installation step S60 may be a step of installing the unit 10 in one or more on the one or more long members 21 of the auxiliary member 20 installed in the building storage space E3 of the building 100.

The unit installation step S60 may be a step of installing a single unit or a plurality of units 10 after adjusting the level of the auxiliary member 20 and installing the auxiliary member 20 in the building storage space E3 of the building 100.
In the unit installation step S60, after the auxiliary member 20 is level-adjusted and installed in either the integrated state or the assembled state of the building storage space E3 of the building 100, the auxiliary member 20 is installed. It may be a step of installing a single or a plurality of units 10 by adjusting the level of the building equipment 11 on the 20 and installing a single or a plurality of units.

In the unit installation step S60, the auxiliary member 20 is level-adjusted and installed in the building storage space E3 of the building 100, and then the building equipment 11 is level-adjusted and installed on the auxiliary member 20, and one or more units 10 are installed. It may be a process of installing.
The unit installation step S60 is performed after adjusting the level of the auxiliary member 20 which is either one of the integrated state or the divided state of the building storage space E3 of the building 100 and installing the auxiliary member 20. It may be a step of installing the building equipment 11 on the member 20 by adjusting the level and installing a single unit or a plurality of units 10.

In the unit installation step S60, the auxiliary member 20 is level-adjusted and installed in the building storage space E3 of the building 100, and then the building equipment 11 is level-adjusted and installed on the auxiliary member 20, and one or more units 10 are installed. It may be a process of installing and installing the production equipment in the building equipment by adjusting the level.
The unit installation step S60 is performed after adjusting the level of the auxiliary member 20 which is either one of the integrated state or the divided state of the building storage space E3 of the building 100 and installing the auxiliary member 20. It may be a step of installing the building equipment 11 on the member 20 by adjusting the level and installing the production equipment in the building equipment by adjusting the level and installing one or more units 10.

The unit installation step S60 may be a step of installing a single unit or a plurality of units in the building storage space E3 of the building 100 after supporting a specific location preset on the auxiliary member 20 and adjusting the level. ..
In the unit installation step S60, the level is adjusted by supporting the auxiliary member, which is either one of the integrated state or the divided state in the building storage space of the building, at a predetermined specific place. It may be a step of installing a single unit or a plurality of units 10 after the installation.

In the unit installation step S60, the auxiliary member 20 is supported in the building storage space E3 of the building 100 at a predetermined specific location, the level is adjusted, and then the building equipment is level-adjusted on the auxiliary member 20. It may be a process of installing a single unit or a plurality of units.
In the unit installation step S60, the level is adjusted by supporting the auxiliary member 20 which is one of the integrated state and the divided state in the building storage space of the building at a predetermined specific place. This may be a step of installing the building equipment on the auxiliary member 20 by adjusting the level and installing the single or a plurality of units 10.

In the unit installation step S60, the auxiliary member 20 is supported in the building storage space E3 of the building 100 at a specific position set in advance, the level is adjusted, and then the building equipment is level-adjusted on the auxiliary member 20. It may be a step of installing and installing the production equipment 12 in the building equipment 11 by adjusting the level and installing a single unit or a plurality of units.
In the unit installation step S60, the auxiliary member 20 which is one of the integrated state or the divided state in the building storage space E3 of the building 100 is supported at a specific position set in advance. After level-adjusting and installing, the building equipment is level-adjusted and installed on the auxiliary member 20, and the production equipment 12 is level-adjusted and installed in the building equipment 11, and one or more units 10 are installed. It may be an installation process.

The overall validity confirmation step S70 is an overall validity confirmation for manufacturing in accordance with the standard / decree / guideline which is one of the predetermined standards, decree, or guidelines for the main equipment installed in the building 100. It is a process to do.

Hereinafter, the operation of the equipment construction method according to the first embodiment of the present invention will be described with reference to the drawings, taking one main equipment as an example.
FIG. 4 shows one main equipment.
One main facility is the facility where the drug is freeze-dried and sealed in a vial.
The main equipment shown in FIG. 4 is composed of a feeder unit 10a, a filling machine unit 10b, a freezing machine unit 10c, a winding machine unit 10d, an external washing machine unit 10e, a freeze dryer 30, and a vial accumulating machine 40.
The feeder unit 10a includes a first construction facility 11a and a feeder isolator 12a that supplies chemicals.
The filling machine unit 10b is composed of a second construction facility 11b and a filling machine iso-R-ta 12b for filling a vial with a drug.
The freezer unit 10c is composed of a third construction facility 11c and a freezer isolator 12c that freezes the chemicals.
The winder unit 10d is composed of a fourth construction facility 11d and a bile winder isolator 12d that winds a lid around the mouth of the vial.
The outer washing machine unit 10e is composed of a fifth construction facility 11e and a vial outer washing machine isolator 12e for externally washing the vial.
The freeze-dryer 30 is a machine that freeze-drys the frozen drug.
The vial accumulator 40 is a machine for accumulating completed vials containing a drug.

The feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are supported by the auxiliary member 20.

A production equipment storage space E1 is formed in each of the supply machine isolator 12a, the filling machine iso-R-ta 12b, the freezer isolator 12c, the bile winding machine isolator 12d, and the vial outer washing machine isolator 12e, which are the production equipment. Will be done.
A building equipment storage space E2 is formed in the first construction equipment 11a, the second construction equipment 11b, the third construction equipment 11c, the fourth construction equipment 11d, and the fifth construction equipment 11E, which are construction equipment.
A building storage space E3 is formed in the building 100.
FIG. 6 shows a state in which a worker is in the building equipment storage space E2 and is working to enclose a drug in a vial in the production equipment storage space E1.

Hereinafter, the operation of the equipment construction method according to the embodiment of the present invention will be described in detail with reference to FIG.

<Unit manufacturing process S20>
FIG. 7A shows how the unit manufacturing process S20 is executed.
In the unit manufacturing factory 200, the feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are assembled on the auxiliary member 20.
When the assembly of the main equipment is completed, the validation step S30 is executed.

<Unit transportation process S40>
The feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are separated into unit units and transported from the unit manufacturing factory 200 to the building.

<Auxiliary member carry-in process S45>
The auxiliary member 20 is carried into the building 100.
FIG. 7C shows how the auxiliary member 20 passes through the opening of the building 100 and is carried into the building 100.

<Unit carry-in process S50>
The feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are carried into the building 100.
In FIG. 7D, the feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e move while being guided by the guide member 22 on the auxiliary member 20. It is shown that they are arranged in series according to a specific order.

<Unit installation process S60>
The main equipment 50 is installed in the building storage space of the building.
In FIG. 7 (E), the first construction equipment 11a, the second construction equipment 11b, the third construction equipment 11c, the fourth construction equipment 11d, and the fifth construction equipment 11e are connected in series in a specific order, and the feeder isolator 12a , The filling machine isolator 12b, the freezer isolator 12c, the vial wrapping machine isolator 12d, and the vial outer washing machine isolator 12e are connected in series in a specific order, and the freeze dryer 30 and the vial accumulator 40 are connected in parallel. The situation is shown.

Next, the equipment construction method according to the second embodiment of the present invention will be described with reference to the drawings.
FIG. 8 is a flow chart No. 1 of the equipment construction method according to the second embodiment of the present invention. FIG. 9 is a flow chart No. 2 of the equipment construction method according to the second embodiment of the present invention. FIG. 10 is a side view of the main equipment according to the second embodiment of the present invention. FIG. 11 is an operation explanatory view 1 of the equipment construction method according to the second embodiment of the present invention. FIG. 12 is an operation explanatory view 2 of the equipment construction method according to the second embodiment of the present invention.

The equipment construction method according to the second embodiment of the present invention includes a building equipment / production equipment preparation process S10, a unit manufacturing process S20, a unit transportation process S40, a unit transfer process S50, and a unit installation process S60.
The equipment construction method according to the second embodiment of the present invention includes a building equipment / production equipment preparation process S10, a unit manufacturing process S20, a unit transportation process S40, an auxiliary member loading process S45, a unit loading process S50, and a unit installation process S60. It may be composed of.
The equipment construction method according to the second embodiment of the present invention includes a building equipment / production equipment preparation process S10, a unit manufacturing process S20, an validity confirmation process S30, a unit transportation process S40, a unit loading process S50, and a unit installation process S60. It is also convenient because it is composed of the overall validity confirmation step S70.
The equipment construction method according to the second embodiment of the present invention includes a building equipment / production equipment preparation process S10, a unit manufacturing process S20, an validity confirmation process S30, an auxiliary member loading process S45, a unit transporting process S40, and a unit loading process S50. It may be composed of the unit installation step S60 and the overall validity confirmation step S70.
The equipment construction method according to the second embodiment of the present invention includes a building equipment / production equipment preparation process S10, a plurality of unit manufacturing processes S20, a plurality of validity confirmation processes S30, an auxiliary member loading process S45, and a unit transportation process S40. It may be composed of a unit carry-in step S50, a unit installation step S60, and an overall validity confirmation step S70.

The configuration of the building equipment / production equipment preparation process S10, the plurality of unit manufacturing processes S20, the plurality of validity confirmation processes S30, the auxiliary member loading process S45, the unit transportation process S40, the unit installation process S60, and the overall validity confirmation process S70 is as follows. Since it is the same as that of the equipment construction method according to the first embodiment, the description thereof will be omitted.

The unit 10 and the auxiliary member 20 may be integrated, and the auxiliary member loading step S45 and the unit transporting step S40 may be executed at the same time.
For example, the integrated unit 10 and auxiliary member 20 are transported from the unit manufacturing factory 200 to the building 100.

The unit loading step S50 is a step of loading a single unit or a plurality of units 10 into the building storage space of the building through an opening provided in the building for each unit.
The unit loading step S50 is a step of loading a plurality of units 10 into the building storage space E3 of the building through an opening provided in the building 100 for each unit.

In the unit carry-in step S50, a single or a plurality of units 10 are supported by a single or a plurality of long members 21 for each unit from an opening provided in the building 100 and guided by the guide member 22 to be carried into the building storage space of the building. It may be a process. ..

In the unit loading step S50, a single or a plurality of units 10 are supported by a single or a plurality of long members 21 for each unit from an opening provided in the building, and are guided by the guide member 22 in a specific order to the building storage space E3 of the building. It may be a process of carrying in.

In the unit loading step S50 for moving the floor, one or more units 10 are supported by one or more long members 21 for each unit from an opening provided in the building, and are integrated with the long members 21 in the building 100. It may be a step of being guided by the guide member 25 so as to move on the floor forming the building storage space E3 and being carried into the building storage space E3.

In the unit loading step S50, a single or a plurality of units 10 are supported by a single or a plurality of long members 21 for each unit from an opening provided in the building 100, and are integrated with the long members 21 to form a storage space in the building 100. It may be a step of being guided by the guide member 25 so as to move along the longitudinal direction of the long member on the floor forming the E3 and being carried into the building storage space E3.

Hereinafter, the operation of the equipment construction method according to the second embodiment of the present invention will be described with reference to the drawings, taking one main equipment as an example.
FIG. 4 shows one main equipment.
One main facility is the facility where the drug is freeze-dried and sealed in a vial.
The main equipment shown in FIG. 4 is composed of a feeder unit 10a, a filling machine unit 10b, a freezing machine unit 10c, a winding machine unit 10d, an external washing machine unit 10e, a freeze dryer 30, and a vial accumulating machine 40.
The feeder unit 10a includes a first construction facility 11a and a feeder isolator 12a that supplies chemicals.
The filling machine unit 10b is composed of a second construction facility 11b and a filling machine iso-R-ta 12b for filling a vial with a drug.
The freezer unit 10c is composed of a third construction facility 11c and a freezer isolator 12c that freezes the chemicals.
The winder unit 10d is composed of a fourth construction facility 11d and a bile winder isolator 12d that winds a lid around the mouth of the vial.
The outer washing machine unit 10e is composed of a fifth construction facility 11e and a vial outer washing machine isolator 12e for externally washing the vial.
The freeze-dryer 30 is a machine that freeze-drys the frozen drug.
The vial accumulator 40 is a machine for accumulating completed vials containing a drug.

The feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are supported by the auxiliary member 20.

A production equipment storage space E1 is formed in each of the supply machine isolator 12a, the filling machine iso-R-ta 12b, the freezer isolator 12c, the bile winding machine isolator 12d, and the vial outer washing machine isolator 12e, which are the production equipment. Will be done.
A building equipment storage space E2 is formed in the first construction equipment 11a, the second construction equipment 11b, the third construction equipment 11c, the fourth construction equipment 11d, and the fifth construction equipment 11E, which are construction equipment.
A building storage space E3 is formed in the building 100.
FIG. 6 shows a state in which a worker is in the building equipment storage space E2 and is working to enclose a drug in a vial in the production equipment storage space E1.

Hereinafter, the operation of the equipment construction method according to the second embodiment of the present invention will be described in detail with reference to FIG.

<Unit manufacturing process S20>
11 (A) and 12 (A) show how the unit manufacturing process S20 is executed.
In the unit manufacturing factory 200, the feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are assembled on the auxiliary member 20.
When the assembly of the main equipment is completed, the validation step S30 is executed.

<Unit transportation process S40>
The feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are separated into unit units and transported from the unit manufacturing factory 200 to the building.

<Auxiliary member carry-in process S45>
The auxiliary member 20 is carried into the building 100.
11 (C) and 12 (C) show how the auxiliary member 20 and the unit 10 are integrally carried into the building 100 through the opening of the building 100.
The auxiliary member 20 and the unit may be carried and carried in as one unit.

<Unit carry-in process S50>
The feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are carried into the building 100.
In FIGS. 11 (D) and 12 (D), the feeder unit 10a, the filling machine unit 10b, the freezing machine unit 10c, the winding machine unit 10d, and the outer washing machine unit 10e are each divided into auxiliary members. It is shown that the guide member 25 guides the machine together with the 20 and moves on the floor of the building and arranges them in series in a specific order.

<Unit installation process S60>
The main equipment 50 is installed in the building storage space of the building.
In FIGS. 11 (E) and 12 (E), the first construction equipment 11a, the second construction equipment 11b, the third construction equipment 11c, the fourth construction equipment 11d, and the fifth construction equipment 11e are connected in series in a specific order. Then, the feeder isolator 12a, the filling machine isolator 12b, the freezer isolator 12c, the vial wrapping machine isolator 12d, and the vial outer washing machine isolator 12e are connected in series in a specific order, and the freeze dryer 30 and the vial accumulator 40 are connected. Are shown in parallel.

FIG. 11 (E) shows how the level adjusting jig 26 supports a structure in which a plurality of long members are rigidly connected by a flange lamp based on the position of the beam to adjust the level.

FIG. 12E shows how both ends of the plurality of elongated members 21 of the auxiliary member 20 coincide with the positions of the beams supporting the floor that form the building storage space of the building.
FIG. 12E) shows how the level adjusting jig 26 supports both ends of the plurality of long members based on the position of the beam and adjusts the level.

The equipment construction method according to the embodiment of the present invention has the following effects depending on its configuration.
The building equipment 11 formed on a panel in which the main equipment 10 is supported by the framework and the production equipment storage space E1 provided in the building equipment storage space E2 of the building equipment 11 and airtightly surrounded by the building equipment storage space E2 are formed. A building 100 composed of a unit 10 having a production facility 12 and forming a building storage space E3 is prepared, and the manufacturing facility 12 is installed in the building facility 11 at the unit manufacturing factory 200 to manufacture the unit 100, and each unit is manufactured. The main equipment 50 was transported from the unit manufacturing factory 200 to the building 100, and each unit was carried into the building storage space E2 of the building 100 through the opening of the building 100, and the main equipment 50 was installed in the building storage space E3. Can be efficiently installed in the building 100.
Further, a plurality of units 10 are arranged directly or in parallel in a specific order, the building equipment 11 of the plurality of units 10 is directly or in parallel, and the production equipment 12 of the plurality of units 10 is directly or in parallel in a specific order. Since the main equipment 50 is installed in the building storage space E3 of the building 100, the main equipment 50 formed by connecting a plurality of units 10 can be efficiently installed in the building.
Further, since the main equipment 10 is installed on the long member 21 of the auxiliary member 20 installed so as to cross the beam in the building storage space E3 of the building 100, the main equipment 10 is installed in the building. Can be installed efficiently.
Further, a single unit or a plurality of units 10 are supported by a long member 21 for each unit from an opening provided in the building 100, and are guided by the guide member 22 in a specific order to be carried into the building storage space E3 of the building 100. Therefore, the main equipment 50 composed of a single unit or a plurality of units 10 can be efficiently installed on the auxiliary member 20 in the building 100.
In addition, since one or more units are supported by the long member for each unit from the opening provided in the building and guided by the guide member so as to move on the long member, they are carried into the building storage space. , The main equipment consisting of one or more units can be efficiently installed on the auxiliary members in the building.
Further, a single or a plurality of units 10 are supported by the long member 21 for each unit from the opening provided in the building 100, and the guide member 25 is moved together with the long member 21 on the floor of the building. Since it is guided and carried into the storage space of the building, the main equipment composed of one or more units can be efficiently installed on the auxiliary members in the building.
Further, the building equipment 11 is installed by adjusting the level on the auxiliary member 20 whose level is adjusted in the unit manufacturing factory 200, and the production equipment 12 is installed and installed in the building equipment 11 by adjusting the level. After that, one or more units 10 are transported, and the building equipment 11 is installed by adjusting the level on the auxiliary member 20 installed by adjusting the level in the building storage space E3 of the building 100, and the main equipment 50 is installed. Therefore, the main equipment 50 can be efficiently installed in the building 100.
In addition, just as the beam of the building supports a specific part of the auxiliary member, the building equipment is installed by adjusting the level on the auxiliary member that supports the specific part and the level is adjusted at the manufacturing factory, and inside the building equipment. The building equipment is leveled on the auxiliary members installed by transporting one or more units manufactured by adjusting the level of the production equipment and supporting it in a specific location in the building storage space of the building. Since the main equipment is installed after adjustment, the main equipment can be installed efficiently in the building.
Further, since the long member 21 is made to be a long member made of a plurality of lattice beams combined in a rectangular shape when viewed from above, a lightweight and highly rigid auxiliary member can be realized.

The present invention is not limited to the embodiments described above, and various modifications can be made without departing from the gist of the invention.
FIG. 2 illustrates, but is not limited to, a particular main facility.

E1 Production equipment storage space E2 Building equipment storage space E3 Building storage space 10 units 10a Supply machine unit 10b Filling machine unit 10c Freezer unit 10d Winding machine unit 10e External washing machine unit 11 Building equipment 11a First construction equipment 11b Second construction Equipment 11c Third construction equipment 11d Fourth construction equipment 11e Fifth construction equipment 12 Production equipment 12a Feeder isolator 12b Filler isolator 12c Freezer isolator 12d Vial wrapping machine isolator 12e Vial outside washer isolator 20 Auxiliary member 21 Long member 22 Guide member 22 Guide member 24 Flange 25 Guide member 26 Level adjustment jig 30 Freezer / dryer 40 Vial stacker 50 Main equipment 100 Building 200 Unit manufacturing factory S10 Building equipment / production equipment preparation process S15 Building identification process S20 Unit manufacturing process S30 Validity confirmation process S40 Unit transportation process S45 Auxiliary member carry-in process S50 Unit carry-in process S60 Unit installation process S70 Overall validity check process

Claims (9)

A method of constructing equipment to produce or manufacture pharmaceuticals, quasi-drugs, medical devices, processed cells, or those containing genes expressed in the body. There,
Building equipment that constitutes one or more units that make up the main equipment, and is a storage space inside. Building equipment that forms a storage space and the building equipment that is installed in the building equipment. Production equipment that is a storage space located inside the space Building equipment / production equipment preparation process that prepares production equipment that is equipment that forms a storage space,
A building identification process that identifies the building that forms the building storage space, which is a storage space that can store the main equipment,
A unit manufacturing process in which the building equipment is installed in a unit manufacturing factory, which is a factory, and the production equipment is installed in the building equipment to manufacture one or more of the units.
A unit transportation process for transporting one or more of the units from the unit manufacturing factory to the building,
A unit loading process in which one or more of the units are carried into the building storage space through an opening provided in the building for each unit.
A unit installation process for installing one or more of the units in the building storage space,
Equipment construction method characterized by being equipped with. The main equipment is composed of a plurality of the above-mentioned units arranged in series or in parallel according to a specific order, which is a specific order.
The main equipment is such that when a plurality of the units are arranged in series or in parallel according to the specific order and the building equipment of the plurality of units is connected, the production equipment of the plurality of units can be connected.
In the unit installation step, a plurality of the units are arranged directly or in parallel according to the specific order in the building storage space of the building, and the building equipment of the plurality of units is connected to form the production equipment of the plurality of units. It is a step of connecting and installing one or more of the above units.
The equipment construction method according to claim 1, wherein the equipment is constructed. Auxiliary member loading process for loading auxiliary members into the building storage space,
With
The auxiliary member has one or more long members capable of supporting all the units constituting the main equipment.
The unit installation step is a step of installing the single or a plurality of the units on the single or a plurality of the long members of the auxiliary member installed in the building storage space.
The equipment construction method according to claim 2, wherein the equipment is constructed. The auxiliary member has one or a plurality of the long members capable of supporting all the units constituting the main equipment in the horizontal direction, and a guide member capable of guiding the unit supported by the long member.
The unit loading step is a step of supporting a single or a plurality of the units from an opening provided in the building by the single or a plurality of the long members for each unit and guiding the unit to the building storage space by being guided by the guide member. Is,
The equipment construction method according to claim 3, wherein the equipment is constructed. A single or a plurality of the long members capable of supporting all the units constituting the main equipment, and the unit supported by the long members along the longitudinal direction of the long members. It has a guide member that can guide the long member so as to move along the longitudinal direction of the long member.
In the unit loading step, one or a plurality of the units are supported by the single or a plurality of the long members for each unit from an opening provided in the building, and the unit is supported on the long members along the longitudinal direction of the long members. It is a process of being guided by the guide member so as to move and carrying it into the building storage space.
The equipment construction method according to claim 4, wherein the equipment is constructed. In the unit manufacturing process, the auxiliary member is installed after adjusting the level in either the integrated state or the assembled state of the divided parts at the unit manufacturing factory, which is a factory. It is a process of manufacturing one or a plurality of the above-mentioned units by adjusting the level of the building equipment and installing the above-mentioned building equipment and adjusting the level of the production equipment in the above-mentioned building equipment.
In the unit installation process, one or a plurality of the auxiliary members are installed after adjusting the level of the auxiliary member in either one of the integrated state or the divided state in the building storage space of the building. This is the process of installing the unit.
The equipment construction method according to claim 5, wherein the equipment is constructed. The unit manufacturing process is a specific place where the auxiliary member is preset, which is either a state of being integrated or a state of being assembled in a divided state at a unit manufacturing factory, which is a factory. After the level is adjusted and installed by supporting with, the building equipment is level-adjusted and installed on the auxiliary member, and the production equipment is level-adjusted and installed in the building equipment. Or it is a process of manufacturing a plurality of the above units.
In the unit installation step, the auxiliary member, which is either one of the integrated state or the divided state in the building storage space of the building, is supported at the specific position set in advance. It is a process of installing one or more of the above units after adjusting the level and installing.
The specific location is a specific location preset on the auxiliary member corresponding to a position of a beam supporting the floor of the building that forms the building storage space when the unit is installed in the building.
The equipment construction method according to claim 6, wherein the equipment is constructed. The long member is a long member made of lattice beams in which the long members are combined in a rectangular shape when viewed from above.
The equipment construction method according to claim 7, wherein the equipment is constructed. Auxiliary member loading process for loading auxiliary members into the building storage space,
With
A single or a plurality of long members capable of supporting all the units constituting the main equipment in which the auxiliary member extends in the horizontal direction and the unit supported by the long member are integrated with the long member in the building. It has a guide member that can guide the user to move on the floor forming the building storage space.
In the unit loading process, the unit or a plurality of the units are supported by the single or a plurality of the long members for each unit from the opening provided in the building, and the unit is integrated with the long members to provide the building storage space of the building. It is a step of being guided by the guide member so as to move on the floor to be formed and carried into the building storage space.
The equipment construction method according to claim 1, wherein the equipment is constructed.

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